Job description:
Location: Milano/Castelvecchio Pascoli, Barga (LU) + Smart Working
Job Summary
The Clinical Study Manager is responsible for the overall planning, coordination, and execution of clinical studies within the pharmaceutical or CRO environment. The role ensures that clinical trials are conducted in compliance with Good Clinical Practice (GCP), applicable regulatory requirements, and internal procedures, while meeting quality, timeline, and budget objectives. The Clinical Study Manager acts as a key point of contact for cross-functional teams and external partners, contributing to the successful delivery of clinical development programs. What you’ll do
* Plan, manage, and oversee assigned clinical studies from start-up through close-out in accordance with study protocols, SOPs, GCP, and regulatory requirements.
* Coordinate and collaborate with internal cross-functional teams (e.g., Clinical Operations, Data Management, Regulatory Affairs, Pharmacovigilance) and external vendors, CROs, and investigators.
* Develop and maintain study timelines, budgets, and tracking tools, ensuring proactive identification and mitigation of risks and issues.
* Monitor study progress, analyze study data and metrics, and ensure timely reporting of study status to stakeholders.
* Ensure proper documentation, filing, and inspection readiness throughout the lifecycle of the clinical study.
* Support problem-solving activities and contribute to continuous improvement of clinical study management processes.
* Prepare and deliver clear and effective communications and presentations to internal teams and external partners in English.
Qualifications and need-to-know
* Scientific degree (e.g., Life Sciences, Pharmacy, Medicine, or related field).
* Minimum of 5 years of experience in clinical study management within the pharmaceutical industry or a CRO.
* Solid working knowledge of Good Clinical Practice (GCP) and relevant international and local regulatory requirements.
* Proven experience with clinical project management methodologies, planning, and tracking tools.
* Strong problem-solving abilities, analytical mindset, and capability to interpret and analyze clinical data.
* Excellent communication and presentation skills, with the ability to interact effectively with multidisciplinary teams.
* Fluency in English, both written and spoken.
This announcement is addressed to applicants of both sexes (L. 903⁄77 - D.Lgs n. 198⁄2006) and also to those belonging to Protected Categories (L.68⁄99).